SANTA BARBARA, Calif.–(BUSINESS WIRE)–Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today noted the presentation of interim study data from the augmentation cohort of its Motiva US IDE Study. This Study Update includes two-year patient follow-up data for primary augmentation subjects. The Medical Director of the Study, Dr. Caroline Glicksman, who is also a Principal Investigator in the Study, is presenting the results today at The Aesthetic Meeting 2022 in San Diego, California.
Dr. Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the two-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at two years was 94.9%. The two-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows:
|
Primary Augmentation |
2-year (N=451), 95% CI |
|
Capsular contracture (Baker Grade III/IV) |
0.5% |
|
Rupture, suspected or confirmed |
0.3% |
|
Breast pain |
0.5% |
|
Infection |
0.9% |
|
Implant removal, with or without replacement |
1.6% |
|
Any reoperation1 |
5.7% |
|
Any complication2 |
7.5% |
|
1. Any surgery on the breast or chest area, device or non-device related, including size change |
|
|
2. Any device or non-device related event, including reoperation |
|
Commenting on the results, Dr. Glicksman said, “The Motiva IDE study is still in its follow-up phase, but the high rate of patient follow-up and preliminary clinical results are encouraging. The clinical study data we will present today adds to a foundation of science and clinical data on Motiva Implants going back eleven years and encompassing over two-million implants. As a study investigator on this rigorous PMA Study, I am proud to be a part of providing women in the United States access to a new class of options in breast implants.”
The Motiva Core pivotal study is an ongoing US clinical trial of an investigational medical device under an FDA-approved Investigational Device Exemption. The Motiva device has not been approved by the Food and Drug Administration and is not commercially available in the United States. This interim report describes preliminary data available to date and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the United States trial. Accordingly, no conclusions should be drawn based on the information presented.
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness. The company’s initial focus is breast health, principally breast aesthetics and reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants® that include a number of innovative and patented features designed to deliver improved aesthetic and clinical outcomes. Since commercial launch in 2010, approximately 2.0 million Motiva Implants® have been delivered to plastic surgeons in over 80 countries. The company also offers or has under development a number of related products and technologies, including the Motiva Flora® tissue expander and Motiva MIA®, the company’s minimally invasive breast enhancement procedure. In 2018, Establishment Labs received an investigational device exemption (IDE) from the FDA for the Motiva Implant® and began a clinical trial to support regulatory approval in the United States. Motiva Implants® are manufactured at the company’s two facilities in Costa Rica, which are compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for additional information at www.establishmentlabs.com.
Forward-Looking Statements
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Contacts
Investor/Media Contact:
Raj Denhoy
415-828-1044
rdenhoy@establishmentlabs.com